Glioblastoma MultiformeMARGANCT05565326
Response Assessment During MR-guided Radiation Therapy for Glioblastoma
An observational study of Glioblastoma Multiforme, run by University of Zurich at 1 site in Switzerland.
Trial summary
The study seeks to assess the response of glioblastoma multiforme to treatment using weekly low field (0.35 T) MR-images of the brain at a MRIdian® linac system during standard radiotherapy at the same system. A total of 20 patients in a single arm will be recruited for this investigation. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Glioblastoma Multiforme
- What is being tested?
- Low field (0.35 T) MR-images of the brain at a MRIdian® linac system
- Type of treatment
- Medical device
- How many people
- 20 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Sep 2022to 31 Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Glioblastoma patients undergoing radio(chemo)therapy.
Who may be able to join
- Subjects fulfilling all of the following criteria are eligible for the study:
- Informed Consent as documented by signature according to Swiss law and ICH/GCP regulations before any trial specific procedures (Appendix I Informed Consent Form)
- Histologically confirmed diagnosis of GBM
- Indication for fractionated radiation therapy for GBM
- Age: ≥ 18 years old
- Gender: any
- Karnofsky performance status ≥60
- Patients who are willing and able to comply with scheduled visits, treatment, and other trial procedures
Who cannot join
- The presence of any one of the following criteria will lead to exclusion of the subject:
- Previous cranial radiation therapy
- Contraindications to MR examinations, e.g., non-compatible implantable device or metallic foreign bodies
- Inability to complete MR examination due to claustrophobic anxiety
- Women who are pregnant or breast feeding,
- Intention to become pregnant during the course of the study
Show all 12Show fewer
- Lack of safe contraception, defined as: Female subjects of childbearing potential, not using and not willing to continue using a medically reliable method of contraception for the entire study duration, such as oral, injectable, or implantable contraceptives, or intrauterine contraceptive devices, or who are not using any other method considered sufficiently reliable by the investigator in individual cases. Female subjects who are surgically sterilized / hysterectomized or post-menopausal for longer than 2 years are not considered as being of child bearing potential.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, diabetes, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia
- Known or suspected non-compliance, drug or alcohol abuse
- Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the subject
- Participation in another study with investigational drug within the 30 days preceding and during the present study
- Enrolment of the investigator, his/her family members, employees and other dependent persons
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site, 1 recruiting
- Recruiting
University Hospital Zurich
Zurich, Canton of Zurich, 8091
Michael Mayinger, MD, +410432530691
About this study
Official title: Pilot Study on Response Assessment During MR-guided Radiation Therapy for Glioblastoma Multiforme
The study seeks to assess the response of glioblastoma multiforme to treatment using weekly low field (0.35 T) MR-images of the brain at a MRIdian® linac system during standard radiotherapy at the same system. A total of 20 patients in a single arm will be recruited for this investigation.
The imaging data will be used to evaluate the change in tumor volume over the course of the treatment and to perform radiomics in order to investigate the possibility of response prediction using these images.
In order to assure sufficient image quality, prior to the main investigation, a group of up to 20 volunteers has MR scans taken with identical sequences to the main study phase.
- Conditions
- Glioblastoma Multiforme
- Being tested
- Low field (0.35 T) MR-images of the brain at a MRIdian® linac system
- Medical subject headings
- Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low field (0.35 T) MR-images of the brain at a MRIdian® linac systemDevice
Low field (0.35 T) MR-images of the brain at a MRIdian® linac system using CE marked low-field MR coils as provided by the company will be taken for volunteers in phase I. In phase II and III, after therapy beginning those images will be taken once per week per subject using CE marked low-field MR coils as provided by the company. This is done over the entire course of radiotherapy, which takes between 3 and 6 weeks.
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess target volume changes with MRI during fractionated MR-guided radiation therapy.
Measured: 6 Months
Secondary outcomes (1)
Value of target changes with MRI during fractionated MR-guided radiation therapy
Measured: 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2022
- Study start1 Sep 2022
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Glioblastoma MultiformeStudies of the same condition, open and under way.
- More trials run by University of ZurichThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Mayinger, University of Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05565326
- Sponsor's protocol ID
- 2021-D0066
- Acronym
- MARGA
- Status last verified
- Feb 2025
- First submitted
- 29 Sep 2022
- Last updated
- 3 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Wallimann P, Wild P, Martirosian P, Schick F, Mayinger M, Boss A, Bink A, Guckenberger M, Tanadini-Lang S, Andratschke N, Pouymayou B. Adaptation of an arterial spin labeling sequence for the assessment of brain perfusion on a 0.35 T MR-Linac. MAGMA. 2026 Feb 12. doi: 10.1007/s10334-026-01326-x. Online ahead of print.
PubMed 41678045
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study on Response Assessment During MR-guided Radiation Therapy for Glioblastoma Multiforme
- ClinicalTrials.gov ID
- NCT05565326
- Acronym / sponsor ID
- MARGA / 2021-D0066
- Conditions
- Glioblastoma Multiforme
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 4 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study seeks to assess the response of glioblastoma multiforme to treatment using weekly low field (0.35 T) MR-images of the brain at a MRIdian® linac system during standard radiotherapy at the same system. A total of 20 patients in a single arm will be recruited for this investigation.
The imaging data will be used to evaluate the change in tumor volume over the course of the treatment and to perform radiomics in order to investigate the possibility of response prediction using these images.
In order to assure sufficient image quality, prior to the main investigation, a group of up to 20 volunteers has MR scans taken with identical sequences to the main study phase.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Glioblastoma patients undergoing radio(chemo)therapy.
Key inclusion criteria (8 listed)
- Informed Consent as documented by signature according to Swiss law and ICH/GCP regulations before any trial specific procedures (Appendix I Informed Consent Form)
- Histologically confirmed diagnosis of GBM
- Indication for fractionated radiation therapy for GBM
- Age: ≥ 18 years old
- Gender: any
Key exclusion criteria (12 listed)
- The presence of any one of the following criteria will lead to exclusion of the subject:
- Previous cranial radiation therapy
- Contraindications to MR examinations, e.g., non-compatible implantable device or metallic foreign bodies
- Inability to complete MR examination due to claustrophobic anxiety
- Women who are pregnant or breast feeding,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low field (0.35 T) MR-images of the brain at a MRIdian® linac systemLow field (0.35 T) MR-images of the brain at a MRIdian® linac system using CE marked low-field MR coils as provided by the company will be taken for volunteers in phase I. In phase II and III, after therapy beginning those images will be taken once per week per subject using CE marked low-field MR coils as provided by the company. This is done over the entire course of radiotherapy, which takes between 3 and 6 weeks. | Device | – |
Primary outcome
To assess target volume changes with MRI during fractionated MR-guided radiation therapy.
Time frame: 6 Months
1 secondary outcome
Value of target changes with MRI during fractionated MR-guided radiation therapy
Time frame: 6 Months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2025.
- Derived from this study: PubMed 41678045Wallimann P, Wild P, Martirosian P, Schick F, Mayinger M, Boss A, Bink A, Guckenberger M, Tanadini-Lang S, Andratschke N, Pouymayou B. Adaptation of an arterial spin labeling sequence for the assessment of brain perfusion on a 0.35 T MR-Linac. MAGMA. 2026 Feb 12. doi: 10.1007/s10334-026-01326-x. Online ahead of print.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Glioblastoma Multiforme, run by University of Zurich at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Michael Mayinger, MD (+41432530691, michael.mayinger@usz.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess target volume changes with MRI during fractionated MR-guided radiation therapy. (time frame: 6 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05565326, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2025.